KCT0005020招募中未知
A 8 week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of CTE on Stomach Symptom
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) Age: 20-70
- •2) Functional dyspepsia by the Rome committe for functional gastrointestinal disorder criteria IV+)
- •*Diagnoses if at least one of the following symptoms is present and there is no abnormal cause in an examination including the upper digestive endoscope (if the symptom starts 6 months prior to Visit 1 and has been present for the last 3 months).
- •-bothersome postprandial fullness
- •-bothersome early satiation
- •-bothersome epigastric pain
- •-bothersome epigastric burning
- •3) GIS(Gastrointestinal Symptom) questionnaire: 4 symptoms among the 10 symptoms , more than 12 points(5-point Likert scale)
- •4) A person who agrees to participate in this human application test and signs a written agreement before the test begins.
排除标准
- •1) In a gastroscopy, an abnormal condition was confirmed. (However, it can be replaced by a test result within 10 months).
- •2) A person with a history of severe malignant tumors, cerebrovascular diseases (brain infarction, cerebral hemorrhage, etc.) and heart diseases (myocardial infarction, heart failure, arrhythmia requiring treatment) within six months of visit 1 (but, in the case of a clinically stable human application test, he or she may participate in the test.)
- •3) A person who has a history of peptic ulcer within six months of visiting1
- •4) Persons with a gastrointestinal surgery history (excluding appendectomy and hemorrhoidectomy)
- •5) Patients with a history of malignant tumors in gastrointestinal tract
- •6) A person who has taken H2 receptor blocker, anti-choline (Muscarin receptor antagonist), gastrin receptor antagonist, prostagladdin drug, proton pump inhibitor, gastrointestinal protection agent, other health-related health-functioning food within two weeks of visit1;
- •7) A person who is required to continue to take drugs that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti-inflammatory drugs and aspirin, during the test period.
- •8) A person who has an average alcohol intake habit of 14 unit per week and 7 unit per week over the past month in a drinking habit survey.
- •9) Patients with unregulated hypertension (measuring standard after 10 minutes stabilization of the person subject to human application test) (above 160mmHg of blood pressure in the retractor or 100mmHg of blood pressure in the retractor).
- •10) Unregulated diabetics (above 180 mg/dl of fasting blood sugar)
- •11) A person whose creatine is more than twice the normal limit of the testing
- •12) A person whose AST (GOT) or ALT (GPT) is at least three times the normal limit of the test
- •13) A person whose Amylase, lipase is more than twice the normal limit of the test
- •14) Any person whose TSH is less than 0.1 µU/ml or greater than 10 µU/ml
- •15) Those who are sensitive or allergic to the ingredients of this test food
- •16) A person who is pregnant, breast-feeding, or planning to conceive within three months.
- •17) A person who has participated in another mediated clinical trial (including a human application test) within one month of visiting1 or who plans to participate in another mediated clinical trial (including a human application test) after the commencement of this test.
- •18) A person who is deemed inappropriate by the tester for the human application test.
研究者
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